# K132672: Extra Corporeal Shockwave Lithotripter

- Pathway: 510(k) (Special)
- Applicant: Dornier Medtech America
- Decided: Sep 23, 2013 after 27 days
- Product code: LNS (Lithotriptor, Extracorporeal Shock-Wave, Urological)
- Device class: 2
- Regulation: 21 CFR 876.5990
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to P840008 (1984). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121656: Gemini Lithotripter, Dornier Medtech America, Inc. (2012) Summary page 1.
- K011873: Dornier Lithotripter S (Doli S) & Dornier Lithotripter S-XP (Doli S-XP), Dornier (2001). Our reading of the summary gave K101873, FDA’s number for Masterscreen Ios (Carefusion Germany 234 GmbH). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “Dornier Doli S XP Lithotripter”.

## Most influential descendants
- K151298: Gemini XXP-HP (2015), 0 descendants of its own

## Indications for use
The Gemini 220 XP is indicated for the fragmentation of urinary tract stones, i.e. renal calyceal stones, renal pelvic stones, and upper ureteral stones.

Source page: https://510kreport.com/device/K132672
Methodology: https://510kreport.com/methodology